The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human deficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.

TORONTO – Its Canadian medical device establishment licence now firmly in hand, Toronto-based Internet of Things Inc. (ITT) is set to launch a fever-detection system for identifying possible COVID-19 carriers at the entrances of airports, long term care facilities, schools and other places where people congregate. The Thermalpass is an AI-enabled, deep learning screening system that got its start as a road-related weather sensing system, today detecting elevated body temperature.

NEW DELHI – A COVID-19 diagnostic test kit developed by the Indian Institute of Technology (IIT) in New Delhi is the latest to join a growing pool of low-cost kits domestically developed in a country where the number of cases topped 2 million in August and continues to rise. The push to develop test kits domestically is part of a national effort to shake off a heavy dependence on imports of medical devices, including diagnostic kits.

Pooled testing was hailed early in the COVID-19 pandemic as a way to quickly and efficiently increase the number of people tested for the virus. But the approach has fallen short of its promise for a variety of reasons, from supply and labor shortages to high community infection rates. Now, a new testing method – recently approved for use by laboratories in Israel – could help chip away at some of those issues.

Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test.

The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification.

Researchers at Ben-Gurion University of the Negev (BGU) presented a new artificial intelligence technique that could protect medical imaging systems from hacking and human errors at the 2020 International Conference on Artificial Intelligence in Medicine (AIME) on Aug. 26. Their innovative solution uses a dual-layer architecture that screens for two different types of anomalous instructions to capture those that are always unusual or outside of safe ranges and those that are inappropriate in the specific context.

A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.

DUBLIN – Liquid biopsy developer Freenome Inc. has – literally – capitalized on its recent proof-of-concept AI-Emerge colorectal cancer (CRC) screening study by raising $270 million in a series C round that will enable the South San Francisco firm to complete its ongoing Preempt CRC registration study and to file for pre-market approval from the FDA.